Chronic Obstructive Pulmonary DiseaseNCT02955108
The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Diseases
A study testing Distractive Auditory Stimuli and No Distractive Auditory Stimuli in people with Chronic Obstructive Pulmonary Disease, run by NYU Langone Health at 1 site in United States.
Trial summary
The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate… Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Distractive Auditory Stimuli and No Distractive Auditory Stimuli
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Oct 2017to 14 Nov 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- English speaking
- aged 40 years or older, with physician-diagnosed COPD
- a flow volume loop with a FEV1/FVC of < 0.70 in the past 12 months
- medically cleared to participate in NYULMC's pulmonary rehabilitation program.
Who cannot join
- Inability to exercise due to musculoskeletalor neurological dysfunction
- Inability to walk independently (unaided)
- deafness or severe hearing impairment requiring hearing aids
- mMRC score = 0 ("I only get breathlessness with strenuous exercise").
Trial locations and contacts
1 site in 1 country.
United States1 site
New York University School of Medicine
New York, New York, 10016
About this study
Official title: The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Disease
The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.
Read the detailed description
This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Distractive Auditory Stimuli, No Distractive Auditory Stimuli
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distractive Auditory StimuliProcedure or surgery
Participants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only.
No Distractive Auditory StimuliProcedure or surgery
Participants will wear headphones with no music playing
| Study group | Role | What they receive |
|---|---|---|
| music first then no music | Experimental | Not described Receives: Procedure: Distractive Auditory Stimuli; Procedure: No Distractive Auditory Stimuli |
| no music first then music | Experimental | Not described Receives: Procedure: Distractive Auditory Stimuli; Procedure: No Distractive Auditory Stimuli |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspnea Intensity (DI)
Borg Breathlessness Scale. The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)". Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64 Validity of the Borg scale for measuring dyspnea intensity has been shown.65
Measured: 60 Minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2016 (estimated)
- Study start27 Oct 2017
- Primary completion14 Nov 2018
- Study completion14 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Maria Norweg, Principal investigator, New York University Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02955108
- Sponsor's protocol ID
- 16-01676
- Status last verified
- Jul 2021
- First submitted
- 2 Nov 2016
- Last updated
- 3 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Distractive Auditory Stimuli (Music) on Dyspnea and Anxiety During Exercise in Adults With Chronic Respiratory Disease
- ClinicalTrials.gov ID
- NCT02955108
- Acronym / sponsor ID
- 16-01676
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 27 Oct 2017 (actual)
- Primary completion
- 14 Nov 2018 (actual)
- Study completion
- 14 Nov 2018 (actual)
- First posted
- 4 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The objective of this study is to look at the effects of distractive auditory stimuli (DAS) on reducing dyspnea intensity and related anxiety and increasing exercise tolerance. Investigators hope that compared to a no-music control condition, that under a music condition participants with COPD will (a) demonstrate increased self-paced walk distance and enjoyment; (b) have less dyspnea intensity, (c) experience less dyspnea anxiety; (d) have less fatigue and state anxiety; and (e) higher maximum heart rate. The upbeat music with a tempo of 90 - 100 bpm (an average-to-moderate walking tempo) is expected to have distractive and performance enhancing effects in order to increase tolerance to dyspnea and exercise. The long-term goal of this study is to increase physical activity in adults with COPD and RLD by promoting dyspnea and fatigue management through use of distractive auditory stimuli in the form of music.
Detailed description
This randomized clinical trial will use a cross-over design. The research will include two within-subject factors, music versus no music and time. Each subject will be randomized a single time to receive either music first then no music, or alternatively, no music first then music during two walk tests.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| music first then no music | Experimental | Procedure: Distractive Auditory Stimuli, Procedure: No Distractive Auditory Stimuli |
| no music first then music | Experimental | Procedure: Distractive Auditory Stimuli, Procedure: No Distractive Auditory Stimuli |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- English speaking
- aged 40 years or older, with physician-diagnosed COPD
- a flow volume loop with a FEV1/FVC of < 0.70 in the past 12 months
Key exclusion criteria (4 listed)
- Inability to exercise due to musculoskeletalor neurological dysfunction
- Inability to walk independently (unaided)
- deafness or severe hearing impairment requiring hearing aids
- mMRC score = 0 ("I only get breathlessness with strenuous exercise").
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Distractive Auditory StimuliParticipants will self-select 1 music piece from a list of choices to keep the rhythm and tempo consistent throughout the 6MWT. The instructions to participants for selecting the music will be standardized. TThe music volume will be standardized to be "moderately loud" as rated by participants for the music condition. Participants will not be specifically instructed to synchronize their walking movements with the music tempo. The music is based on a cognitive therapy (distraction) strategy conceptual framework. Music will be played during the 6MWT (in-task) only. | Procedure or surgery | music first then no music, no music first then music |
| No Distractive Auditory StimuliParticipants will wear headphones with no music playing | Procedure or surgery | music first then no music, no music first then music |
Primary outcome
Dyspnea Intensity (DI)
Time frame: 60 Minutes
Borg Breathlessness Scale. The Borg dyspnea scale is a single-item rating scale, ranging between 0, "nothing at all", and 10, "very, very severe (maximal)". Patients will be asked to rate their level of dyspnea during the walk test using the 10-point Borg scale after the 6MWT.64 Validity of the Borg scale for measuring dyspnea intensity has been shown.65
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Maria Norweg principal investigator
New York University Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distractive Auditory Stimuli and No Distractive Auditory Stimuli in people with Chronic Obstructive Pulmonary Disease, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspnea Intensity (DI) (time frame: 60 Minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2021.